The Recall Desk

FDA (Drugs) recall action 77009

Standard Homeopathic Company recalled 2 products on 2017-05-31

The FDA (Drugs) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2017-05-31
Critical
2
Units
10,955,700

Why these products were recalled

Superpotent Drug: FDA analysis found inconsistent amounts of belladonna alkaloids that may differ from the calculated amount on the product labels.

Superpotent Drug: FDA analysis found inconsistent amounts of belladonna alkaloids that may differ from the calculated amount on the product labels.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–2 of 2

  • CriticalFDA (Drugs)··2017-05-31

    Hyland's Baby Teething Tablets Recalled for Inconsistent Belladonna Alkaloid Levels

    Standard Homeopathic Company is recalling Hyland's Baby Teething Tablets because FDA analysis found inconsistent amounts of belladonna alkaloids that may differ from label claims.

    Product
    Hyland's Baby Teething Tablets [Calcarea Phosporica 6X HPUS, Chamomilla 6X HPUS, Coffea Cruda 6X HPUS, Belladonna 12X HPUS (0.0000000000003% alkaloids, calculated)] Quick-Dissolving Tablets, packaged in a) 40-count bottles (NDC 54973-3127-3) (UPC 3 54973 31273 9); b) 135-count bo
    Category
    Distribution
    1 state
  • CriticalFDA (Drugs)··2017-05-31

    Hyland's Baby Nighttime Teething Tablets Recalled for Inconsistent Belladonna Alkaloids

    Standard Homeopathic Company is recalling Hyland's Baby Nighttime Teething Tablets because FDA analysis found inconsistent amounts of belladonna alkaloids.

    Product
    Hyland's Baby Nighttime Teething Tablets [Belladonna 12X HPUS (0.0000000000003% alkaloids, calculated), Calcarea Phosphorica 6X HPUS, Chamomilla 6X HPUS, Coffea Cruda 6X HPUS, Magnesia Phosphorica 6X HPUS, Rheum 6X HPUS, Silicea 12X HPUS] Quick-Dissolving Tablets, 135-count bottl
    Category
    Distribution
    1 state